Artiss News

INDICATIONS AND USAGE

ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.

ARTISS is not indicated for hemostasis.

DOSAGE AND ADMINISTRATION

FOR TOPICAL USE ONLY – DO NOT INJECT.

The required dose of ARTISS depends on the size of the surface to be covered. The approximate surface areas covered by each package size of ARTISS are:

Table 1.

Approximate area requiring skin graft fixation

Required package size of ARTISS

100 cm2

2 mL

200 cm2

4 mL

500 cm2

10 mL

It is recommended that every time a patient receives a dose of ARTISS the name and lot number (batch number) of the product are documented in order to maintain a record of the batches used.

Preparation of ARTISS Kit (Freeze-Dried)

During preparation of ARTISS Kit:

DO NOT EXPOSE TO TEMPERATURES ABOVE 37°CDO NOT REFRIGERATE OR FREEZE AFTER RECONSTITUTION

Do not use iodine or heavy metal containing preparations such as betadine for disinfection of vial stoppers. Allow alcohol-based disinfectants to evaporate before puncturing stopper.

After reconstitution, the product must be used within 4 hours.

Use separate syringes for reconstituting Sealer Protein and Thrombin solutions and for application to prevent premature clotting.

ARTISS Kit contains the following substances in four separate vials:

-Sealer Protein Concentrate (Human)

-Fibrinolysis Inhibitor Solution (Synthetic)

-Thrombin (Human)

-Calcium Chloride Solution

Freeze-dried Sealer Protein Concentrate and Thrombin are reconstituted in Fibrinolysis Inhibitor Solution and Calcium Chloride Solution, respectively. The Sealer Protein Solution and Thrombin Solution are then combined using the DUPLOJECT Preparation and Application System, or an equivalent delivery device cleared by FDA for use with ARTISS to form the Fibrin Sealant.

Prewarming ARTISS Kit with FIBRINOTHERM

If a FIBRINOTHERM device is not available, contact Baxter (1-800-423-2090) for assistance. See FIBRINOTHERM manual for complete operating instructions.

Plug the FIBRINOTHERM Heating and Stirring Device into an electrical socket and activate the warmer (amber switch). Ensure that the stirring mechanism of the FIBRINOTHERM device is initially switched off (green switch).

Place all four vials from the ARTISS Kit into the prewarmed wells of the FIBRINOTHERM, using the appropriately sized adapter rings, and allow the vials to warm for up to 5 minutes (room temperature product may take less time).

Preparation of Sealer Protein Solution with FIBRINOTHERM

Remove the flip-off caps from the vial containing the Sealer Protein Concentrate and the vial containing the Fibrinolysis Inhibitor Solution, disinfect the rubber stoppers of both vials with a germicidal solution and allow to dry.

Transfer the Fibrinolysis Inhibitor Solution into the vial containing the freeze-dried Sealer Protein Concentrate using the sterile reconstitution components provided with the DUPLOJECT Preparation and Application System, or an equivalent device cleared by FDA for use with ARTISS (see directions provided with the device system for specific reconstitution instructions). Gently swirl the vial to ensure that the freeze-dried material is completely soaked.

Place the vial into the largest opening of the FIBRINOTHERM device with the appropriate adaptor. Switch on the stirrer (green switch) and allow the vial contents to stir until all Sealer Protein Concentrate is dissolved.

Reconstitution of the freeze-dried Sealer Protein Concentrate is complete as soon as no undissolved particles are visible. Otherwise, return the vial to the FIBRINOTHERM device and agitate for a few more minutes until the solution appears homogeneous.

Notes:

Do not use the Sealer Protein Concentrate until it has fully dissolved. If the Sealer Protein Concentrate has not dissolved within 20 minutes using the FIBRINOTHERM device, discard the vial and prepare a fresh kit. Excessive stirring (20 minutes or more) may compromise product quality.

If not used promptly, keep the Sealer Protein Solution at 37°C without stirring. To ensure homogeneity, switch on the stirrer of the FIBRINOTHERM device shortly before drawing up the solution.

Preparation of Thrombin Solution with FIBRINOTHERM

Remove the flip-off caps from the vial containing Thrombin and the vial containing Calcium Chloride Solution, disinfect the rubber stoppers of both vials with a germicidal solution and allow to dry.

Transfer the contents of the vial with Calcium Chloride Solution into the vial containing the freeze-dried Thrombin using the sterile reconstitution components provided with the DUPLOJECT Preparation and Application System, or an equivalent device cleared by FDA for use with ARTISS (see directions provided with the device system for specific reconstitution instructions).

Swirl briefly.

Place the vial into the adapted opening of the FIBRINOTHERM device.

Reconstitution of Thrombin is complete when all of the Thrombin concentrate is dissolved.

Keep the Thrombin Solution at 37°C until used.

Transferring to the Sterile Field

For transfer of the Sealer Protein Solution and the Thrombin Solution to the sterile field, the scrub nurse should withdraw the solutions while the circulating nurse holds the non-sterile vials. The solutions should be withdrawn slowly by firm constant aspiration to reduce the risk of large air bubbles.

See
DOSAGE AND ADMINISTRATION, Method of Application.

Preparation of ARTISS Pre-filled Syringe (Frozen)

During preparation of ARTISS (frozen):

DO NOT EXPOSE TO TEMPERATURES ABOVE 37°CDO NOT MICROWAVEDO NOT REFRIGERATE OR RE-FREEZE AFTER THAWING

Do not use ARTISS (frozen) unless it is completely thawed and warmed (liquid consistency).

Do not remove the protective syringe cap until thawing is complete and the application tip is ready to be attached.

ARTISS (frozen) can be prepared (thawed) using one of two options:

Room Temperature Thawing

Approximate thawing times when using this method are:

Pack Size

Room Temperature(In Pouches)

2 mL

60 minutes

4 mL

110 minutes

10 mL

160 minutes

Unopened pouches, thawed at room temperature, may be stored for up to 14 days at 15-25°C.

Prior to use, the product should be warmed to 33-37°C:

Pack Size

33°C to 37°C Incubator(In Pouches)

2 mL

15 minutes

4 mL

25 minutes

10 mL

35 minutes

Quick Thawing

Thawing on the sterile field using a water bath

33°C to 37°C sterile water bath - transfer the inner pouch to the sterile field, remove pre-filled syringe from inner pouch and place directly into sterile water bath. Ensure the contents of the pre-filled syringe are completely immersed under the water.

Approximate thawing times when using this method are:

Pack Size

33°C to 37°C Sterile Water Bath(Pouches Removed)

2 mL

5 minutes

4 mL

5 minutes

10 mL

12 minutes

Thawing off the sterile field using a water bath

33°C to 37°C non-sterile water bath in two pouches - maintain the pre-filled syringe in both pouches and place into a water bath off the sterile field for appropriate time. Ensure the pouches remain submerged throughout thawing. Remove from the water bath after thawing, dry external pouch and transfer inner pouch with pre-filled syringe onto the sterile field.

Approximate thawing times when using this method are:

Pack Size

33°C to 37°C Non-Sterile Water Bath(In Pouches)

2 mL

30 minutes

4 mL

40 minutes

10 mL

80 minutes

Thawing off the sterile field using an incubator

33°C to 37°C incubator in pouches – maintain the pre-filled syringe in both pouches and place into an incubator for appropriate time. Remove from incubator after thawing and transfer inner pouch with pre-filled syringe onto the sterile field.

Approximate thawing times when using this method are:

Pack Size

33°C to 37°C Incubator(In Pouches)

2 mL

40 minutes

4 mL

85 minutes

10 mL

105 minutes

Maintain the product at 33-37°C until use. If product is removed from original pouch or warmed to 33-37°C it must be used within 12 hours.

See
DOSAGE AND ADMINISTRATION, Method of Application.

Method of Application

Apply ARTISS using the Easyspray and Spray Set, or an equivalent device cleared by FDA for application of ARTISS. See additional instructions for use provided with the spray set.

The wound surface should be as dry as possible before application.

Apply ARTISS as a thin layer to avoid the formation of excess granulation tissue and to ensure gradual absorption of the polymerized fibrin sealant. The aerosolized sealant should be applied to the wound in a painting motion from side to side to achieve a single thin application. The wound bed will glisten in the area to which fibrin sealant has been applied. Any areas not covered by fibrin sealant will be clearly visible. The skin graft should be attached to the wound bed immediately after ARTISS has been sprayed. The surgeon has approximately 60 seconds to manipulate and position the graft prior to polymerization. To prevent adherence, wet gloves with normal saline before product contact.

After the graft has been applied, hold in the desired position by gentle compression for at least 3 minutes to ensure ARTISS sets properly and adheres firmly to the surrounding tissue. The solidified fibrin sealant reaches its final strength in approximately 2 hours after application.

The cannulas included with the DUPLOJECT Preparation and Application System or DUO Set may be used for small wounds or for edges of a skin graft that did not adhere to the wound bed (see WARNINGS/PRECAUTIONS Application Precautions (5.2)). Immediately before application, expel and discard the first several drops from the application cannula to ensure adequate mixing of the Sealer Protein and Thrombin solutions.

Freeze-Dried: Refer to instructions for use provided with the DUPLOJECT Preparation and Application System.

Frozen: DUO Set Instructions (see Figure 1 below):

Insert plunger into syringe barrel.

Firmly connect the two syringe nozzles to the joining piece and secure it by fastening the tether strap to the syringe.

Fit an application cannula to the joining piece.

If application of ARTISS is interrupted, replace the cannula immediately before application is resumed.

Figure 1 DUO SET A

Vials and pre-filled syringes are for single use only. Discard unused contents.

DOSAGE FORMS AND STRENGTHS

Presentations and Pack Sizes

ARTISS Kit (Freeze-Dried) is supplied as 2 mL, 4 mL and 10 mL (total volume) pack sizes with and without the DUPLOJECT Preparation and Application System.

Other ingredients include: human albumin, sodium chloride and water for injection (WFI).

1 The potency expressed in units is determined using a clotting assay against an internal reference standard for potency that has been calibrated against the World Health Organization (WHO) Second International Standard for Thrombin, 01/580. Therefore, a unit (U) is equivalent to an International Unit (IU).

HOW SUPPLIED/STORAGE AND HANDLING

ARTISS is supplied in the following pack sizes and presentations:

Table 4.

Pack Size

NDC Number

ARTISS Kit (Freeze-Dried)

ARTISS Kit (Freeze-Dried) with DUPLOJECT System

ARTISS Pre-Filled Syringe (Frozen) with DUO Set

2 mL

0944-4351-03

0944-4351-04

0944-8503-02

4 mL

0944-4351-07

0944-4351-08

0944-8503-04

10 mL

0944-4351-11

0944-4351-12

0944-8503-10

See
DOSAGE FORMS AND STRENGTHS, Package Contents
.

Storage

Store ARTISS in original carton to protect from light.

ARTISS Kit (Freeze-Dried)

Store at 2°C to 25°C. Avoid freezing. After reconstitution, the product must be used within 4 hours. Reconstituted solutions must not be refrigerated or frozen.

ARTISS Pre-filled Syringe (Frozen)

Long term:

Store at ≤ -20°C.

Short term:

Room Temperature Thawing: Unopened pouches, thawed at room temperature, may be stored for up to 14 days at room temperature (15-25°C) after removal from the freezer.

Quick Thawing: Maintain the product at 33-37°C until use. If the product is removed from original pouch or warmed to 33-37°C it must be used within 12 hours.

Do not refrigerate or re-freeze after thawing. Do not microwave.

Do not use after the expiration date. Discard if packaging of any components is damaged.